MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM? CRT-D; Cardiac resynchronization therapy defibrillator (CRT-D)

Model Number	G125
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited oversensed noise and pacing inhibition.The patient experienced dizziness.Technical services (ts) was contacted and noted that the noise appeared to be electromagnetic interference (emi).Ts also recommended follow up.This crt-d remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: MOMENTUM? CRT-D
• Common Device Name: Cardiac resynchronization therapy defibrillator (CRT-D)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50869893
• Report Number: 2124215-2026-50675
• Device Sequence Number: 18469983
• Product Code: NIK
• UDI-Device Identifier: 00802526589126
• UDI-Public: (01)00802526589126(17)220312
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/12/2022
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 139224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/23/2026
• Supplement Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 03/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female